Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Display, Diagnostic Radiology
510(k) Number K230723
Device Name C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor
Applicant
Nanjing Jusha Display Technology Co., Ltd.
8a, Block 1. Nanjing International Service Outsourcing
Mansion, # 301, Hanzhongmen St.
Nanjing,  CN 210036
Applicant Contact Donny Lee
Correspondent
Nanjing Jusha Display Technology Co., Ltd.
8a, Block 1. Nanjing International Service Outsourcing
Mansion, # 301, Hanzhongmen St.
Nanjing,  CN 210036
Correspondent Contact Donny Lee
Regulation Number892.2050
Classification Product Code
PGY  
Date Received03/16/2023
Decision Date 05/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-